Quality Assurance Specialist with German and English

vor 1 Monat


City Kreis Zürich, Schweiz Lonza Vollzeit

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. And that’s the kind of work we want to be part of.
For Drug Product Services (DPS) , our successful DP focused branch located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for Quality Assurance Expert for pharmaceutical QMS and combination products.
Executes, establishment and maintenance of the Pharmaceutical Quality Management System at Drug Product Services for manufacturing of sterile products including combination products
Supports the organization in compliance topics as part of the QA Compliance team including but not limited to CAPAs, self-inspections, KPIs, assess GMP training requirements
Assist the line functions in the creation and monitoring of quality processes related to the relevant parts of the Quality Management System for combination products
Act as author and approve corresponding guidance documents and be first contact concerning methods, validation and testing and acting in any compliance issue for combination products
Tracking GMP status of service providers (e.g. calibration, maintenance, consultants) tracking SAP material and supplier master data
Act as QA representative for the packaging team by approving methods, laboratory reports and development activities
Significant working experience in Quality Assurance in pharmaceutical industries and GMP environment preferable in sterile manufacturing
Sound knowledge in compliance systems for document life cycle management, workflow tools (e.g. Document Management System) and processes for sterile Drug Product manufacturing incl testing
Exceptional communication skills as well as customer focus (intern/external)
Excellent knowledge of written and spoken English, basic knowledge of German



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